The global biosimilars market is segmented on the basis of products, applications, and services.The global biosimilars market is estimated to be $783 million in 2013 and will grow at a CAGR of 20.1%by 2018.

The demand for biosimilars is expected to grow considerably in the coming years, owing to their higher efficacies than their chemical counterparts and also because they are priced lower than branded products. This increase in demand can also be attributed to increased penetration in some countries and the rising demand from therapeutic areas such as oncology, hormonal disorders, and autoimmune disorders. In addition, biosimilars help in reducing healthcare costs, a challenge faced by the global healthcare industry.

The notable drivers for the biosimilars market are increasing pressure to cut healthcare expenditures, increase in aging population, growing demand for biosimilar drugs due to their cost effectiveness, rising incidences of various diseases, strategic collaborations that lead to increased productivity and clinical trial activities, and government support and initiatives.
However, the major restricting factors are high manufacturing complexities and costs, stringent regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to extend their patent protection.

The biosimilars market is studied for major countries in four major regions, namely, North America (U.S. and Canada), Europe (U.K., Germany, France, Spain, Italy, and RoE), Asia-Pacific (India, China, Japan, South-Korea, and RoAP), and the Rest of the World (RoW) (Latin America, Africa, and the MiddleEast). Europe is the largest market for biosimilars, followed by Asia-Pacific. The U.S., on the other hand, has a very restricted biosimilars market owing to the stringent regulatory environment in North America. The Asia-Pacific market is estimated to be the fastest-growing market. Among the Asia-Pacific countries, China and India are expected to grow at the fastest pace. Other countries such as U.S., South Korea, and Brazil are also poised to register highgrowth over the next five years.

The key players in the global biosimilars market are Sandoz (Germany), Hospira (U.S.), Teva (Israel), Dr. Reddy’s Laboratories (India), Biocon Ltd. (India), Mylan (U.S.), Biopartners (Switzerland), Amgen (U.S.), and Intas Biopharmaceultical Ltd. (India). Sandoz has emerged as the market leader in the global biosimilars market and is likely to maintain this leadership position in the coming years. Sandoz entered the biosimilars market in 2006 with the launch of Omnitrope (human growth hormone)-a biosimilar drug-in the European market. Sandoz’s biosimilar product offerings include Zarzio (G-CSF), Omnitrope (Human Growth Hormone), and Binocrit (epoeitin-alpha). Thus, a broad product portfolio enables the company to gain a competitive advantage over other players in the market. The company focuses on strengthening its market position by significantly investing in research and development activities. It has a robust biosimilar pipeline with about 10 drugs. Of all the biosimilars in the pipeline, four biosimilars are currently in the phase III trials (including monoclonal antibodies, a biosimilar version of the originator compound rituximab for the treatment of follicular lymphoma) and a biosimilar in phase II trial for rheumatoid arthritis. The other molecules undergoing phase III testing are biosimilar versions of peg-filgrastim and epoetin-alfa.

Extensive research in this market has brought to light that agreements, partnerships, strategic alliances, and collaborations together was found to be the key strategy followed by industry players. During 2010 to 2013, the industry witnessed 21 different agreements and collaborations by players. The major players involved in this section are Amgen, Inc. (U.S.), Biocon Ltd. (India), and Celltrion, Inc. (Korea). For instance, Biocon Ltd. entered into an agreement with Mylan, Inc. in February 2013 for the development and commercialization of generic versions of Biocon’s three insulin analog products. The agreement helped both the companies to build a strong global presence in generic insulin analogs and provided affordable therapy options to physicians, healthcare providers, and diabetes patients, globally. Additionally, these companies invested significant amounts in R&D for biosimilars, especially monoclonal antibodies to treat cancer (oncology), autoimmune disorders, and infectious diseases. For instance,
BioXpress has 16 MAbs in pipeline, while GeneTechno Science of Japan has 6 MAbs for different therapeutic areas. Other key products that have gained maximum attention from drug makers are insulin, interferons, filgrastim, erythropoietin, and follitropin.

About MarketsandMarkets
MarketsandMarkets is a global market research and consulting company based in the U.S. We publish strategically analyzed market research reports and serve as a business intelligence partner to Fortune 500 companies across the world.